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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/13; CORONARY DRUG-ELUTING STENT

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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/13; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 364476
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2020
Event Type  malfunction  
Event Description
The orsiro drug-eluting stent system was selected for use.The orsiro could not pass the lesion and upon removal a stent deformation was noticed.
 
Manufacturer Narrative
Combination product: yes.Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in process and final inspection.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.
 
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Brand Name
ORSIRO 2.5/13
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
MDR Report Key10473368
MDR Text Key205006012
Report Number1028232-2020-03681
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
P170030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/02/2021
Device Model Number364476
Device Catalogue NumberSEE MODEL NO.
Device Lot Number09194338
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/31/2020
Initial Date FDA Received08/31/2020
Supplement Dates Manufacturer Received10/13/2020
Supplement Dates FDA Received10/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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